In modern medicine it is often desirable and frequently necessary to harvest tissue samples from a target tissue region or tissue site inside a human or animal body for the purpose of diagnosing a suspected malignancy. Currently available biopsy devices offer several ways of accessing suspect tissue and of harvesting tissue samples that may be used for diagnostic purposes, and some also comprise temporary storage solutions that may be used to hold tissue samples during a biopsy procedure. Such a biopsy device is disclosed in U.S. Pat. No. 5,526,822. The disclosed biopsy device is capable of harvesting multiple tissue samples in a single device insertion and features a cassette with multiple tissue chambers, permitting the temporary storage of multiple tissue samples.
However, none of the currently available biopsy devices and systems address all the functions and provide all the interfaces between functions that are involved in harvesting a tissue sample and getting the tissue sample to the pathologist in uncontaminated or undisturbed condition. Another important aspect of the present invention is to provide biopsy devices and systems that minimize operator exposure to bio-hazards, bio-contaminants as well as formalin and other known and probable human carcinogens. The current lack of commercially available biopsy devices and systems with one or both of these capabilities is problematic for several reasons.
New and improved diagnostic techniques—such as cytogenetic, immunological and biochemical analyses require that the tissue samples be handled with extreme care. Since tissue architecture is an important parameter in the histologic analysis of samples it is important that handling of acquired tissue samples is minimized.
Human tissues are potentially infectious, and an operator increases his exposure to such infection by physically handling tissue samples. Given this, limiting operator exposure to tissue samples is a sensible precaution. Currently available systems, such as is disclosed in U.S. Pat. No. 5,526,822, provide means for temporarily storing one or more tissue samples during a biopsy procedure, but no means are provided for transferring such tissue samples to more permanent storage containers where preservation and fixation of the tissue samples is possible. In use, these systems therefore require that the operator or an assistant manually transfer samples from the temporary storage means included in the biopsy device to more permanent storage means if said samples are to be fixated prior to being sent to a pathologist or similarly skilled individual for analysis.
Another problem that has received little attention in the design of presently available biopsy systems is the use of formalin or similar preserving agents to fixate tissue samples subsequent to their extraction from the patient. Formalin is classified by the WHO and IARC as a known carcinogen and at least some countries have imposed limits on the permissible exposure. These limits include upper limits on the amount of airborne formalin and such upper limits have forced some hospitals to implement ventilation and suction systems to protect doctors and assistants from excessive exposure to formalin. Such implementation programs—when possible—are costly and potentially disruptive to established biopsy procedure routines.
Therefore, a biopsy device and system according to the present invention that comprise all necessary components and functionalities for safely and efficiently harvesting one or more tissue samples in a single device insertion are highly advantageous. Furthermore, such biopsy device and system may advantageously comprise means for temporarily storing harvested tissue samples in individual compartments during the biopsy procedure while permitting the operator/doctor to inspect each tissue sample for adequacy, as well as means for more permanently storing and fixating the samples once the harvesting is over. Ideally, transfer of the tissue samples between the temporary storage means included in the biopsy device and the permanent storage means should be possible without requiring that the operator removes the samples from their individual compartments thereby minimizing the exposure of the operator to bio-hazards and bio-contamination. In addition, such a comprehensive biopsy device and system would also provide means for aggregating formalin or a similar preserving and fixating agent while maintaining at all times a closed environment, to eliminate operator exposure to such substances.